The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial.

This is the final version of the article. Available from Biomed Central via the DOI in this record.BACKGROUND: Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. METHODS/DESIGN: This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT) will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75) will be randomized to one of three conditions: control (an interview involving a general discussion about the center); goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement); or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring). All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life), cognitive (memory and executive function), and physical fitness (functional and metabolic) domains. Cost-effectiveness will also be examined. DISCUSSION: This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. TRIAL REGISTRATION: Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com).This study is funded by the Medical Research Council (UK) through the Lifelong Health and Well-being programme. The funder plays no role in the design of the study, in the collection, analysis and interpretation of data, or in the decision to submit the manuscript for publication. Professors Carol Brayne, Martin Knapp, Mike Martin, and Robin Morris advised on and critically reviewed the study proposal. John Clifford Jones, Maldwyn Roberts, and Stephen Williams of Age Cymru Gwynedd a Môn are responsible for setting up and managing the Nefyn AgeWell Centre. Julie Nixon is conducting the interviews and Jennifer Cooney is contributing to data collection. Anne Krayer will collect and analyze qualitative data for the biographical narrative analysis. Blood samples are analyzed by NHS laboratory staff at Ysbyty Gwynedd, Bangor. Sources of funding for each author are as follows: LC: Higher Education Funding Council for Wales; JVH: National Health Service/ Welsh Assembly Government; IRJ: Higher Education Funding Council for Wales; SMN: Medical Research Council grant; JT: Higher Education Funding Council for Wales; CJW: Welsh Assembly Government

Equity of access to treatment on the Cancer Drugs Fund:A missed opportunity for cancer research?

AbstractUsing mixed-methods, we investigated the CDF in the South West of England (3193 cancer patients treated through the CDF, April 1st 2011–March 31st 2013) for evidence of: (1) equitable access across socioeconomic groups, age groups, sex, and Cancer Network; (2) time-to-treatment by socioeconomic group; and (3) the perception of the CDF as fair, using semi-structured interviews with oncology consultants.There was no evidence of inequitable access to anti-cancer therapy for those in more deprived areas. For all cancer types, there was a lower proportion of women in the CDF cohort than in the Cancer Registry reference population (e.g., melanoma, CDF 36.8% female, reference population 48.7%; difference 11.9%, 95% CI 3.1–20.7%). There was a lower proportion of older patients in the CDF compared with the reference population (e.g., colorectal cancer, CDF 6.9% ≥80 years, reference population 30.1%; difference 23.2%, 95% CI 20.2–26.2%). Interviewed oncologists felt differences in performance status, not age, influenced referral to the CDF, with neither deprivation, nor gender contributing.Our study suggests that the CDF has differential access by age and sex, but not by deprivation. The absence of high quality CDF data represents a missed opportunity to fully evaluate equity of access and the real-world costs and outcomes of novel anti-cancer drugs

Unsupervised machine learning of integrated health and social care data from the Macmillan Improving the Cancer Journey service in Glasgow

Background: Improving the Cancer Journey (ICJ) was launched in 2014 by Glasgow City Council and Macmillan Cancer Support. As part of routine service, data is collected on ICJ users including demographic and health information, results from holistic needs assessments and quality of life scores as measured by EQ-5D health status. There is also data on the number and type of referrals made and feedback from users on the overall service. By applying artificial intelligence and interactive visualization technologies to this data, we seek to improve service provision and optimize resource allocation.Method: An unsupervised machine-learning algorithm was deployed to cluster the data. The classical k-means algorithm was extended with the k-modes technique for categorical data, and the gap heuristic automatically identified the number of clusters. The resulting clusters are used to summarize complex data sets and produce three-dimensional visualizations of the data landscape. Furthermore, the traits of new ICJ clients are predicted by approximately matching their details to the nearest existing cluster center.Results: Cross-validation showed the model’s effectiveness over a wide range of traits. For example, the model can predict marital status, employment status and housing type with an accuracy between 2.4 to 4.8 times greater than random selection. One of the most interesting preliminary findings is that area deprivation (measured through Scottish Index of Multiple Deprivation-SIMD) is a better predictor of an ICJ client’s needs than primary diagnosis (cancer type).Conclusion: A key strength of this system is its ability to rapidly ingest new data on its own and derive new predictions from those data. This means the model can guide service provision by forecasting demand based on actual or hypothesized data. The aim is to provide intelligent person-centered recommendations. The machine-learning model described here is part of a prototype software tool currently under development for use by the cancer support community.Disclosure: Funded by Macmillan Cancer Support</p

Topiramate add-on therapy for drug-resistant focal epilepsy

Background The majority of people with epilepsy have a good prognosis and their seizures are controlled by a single antiepileptic drug. However, up to 20% of patients from population‐based studies, and up to 30% from clinical series (not population‐based), develop drug‐resistant epilepsy, especially those with focal‐onset seizures. In this review, we summarise the current evidence regarding topiramate, an antiepileptic drug first marketed in 1996, when used as an add‐on treatment for drug‐resistant focal epilepsy. This is an update of a Cochrane Review first published in 1999, and last updated in 2014. Objectives To evaluate the efficacy and tolerability of topiramate when used as an add‐on treatment for people with drug‐resistant focal epilepsy. Search methods For the latest update of this review we searched the following databases on 2 July 2018: Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (Ovid, 1946‐ ); ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We imposed no language restrictions. We also contacted the manufacturers of topiramate and researchers in the field to identify any ongoing or unpublished studies. Selection criteria Randomised, placebo‐controlled add‐on trials of topiramate, recruiting people with drug‐resistant focal epilepsy. Data collection and analysis Two review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: (1) 50% or greater reduction in seizure frequency; (2) seizure freedom; (3) treatment withdrawal (any reason); (4) adverse effects. Primary analyses were intention‐to‐treat (ITT), and summary risk ratios (RRs) with 95% confidence intervals (95% CIs) are presented. We evaluated dose‐response in regression models. We carried out a 'Risk of bias' assessment for each included study using the Cochrane 'Risk of bias' tool and assessed the overall certainty of evidence using the GRADE approach. Main results We included 12 trials, representing 1650 participants. Baseline phases ranged from four to 12 weeks and double‐blind phases ranged from 11 to 19 weeks. The RR for a 50% or greater reduction in seizure frequency with add‐on topiramate compared to placebo was 2.71 (95% CI 2.05 to 3.59; 12 studies; high‐certainty evidence). Dose regression analysis showed increasing effect with increasing topiramate dose demonstrated by an odds ratio (OR) of 1.45 (95% CI 1.28 to 1.64; P < 0.001) per 200 mg/d increase in topiramate dosage. The proportion of participants achieving seizure freedom was also significantly increased with add‐on topiramate compared to placebo (RR 3.67, 95% CI 1.79 to 7.54; 8 studies; moderate‐certainty evidence). Treatment withdrawal was significantly higher for add‐on topiramate compared to placebo (RR 2.37, 95% CI 1.66 to 3.37; 12 studies; high‐certainty evidence). The RRs for the following adverse effects indicate that they are significantly more prevalent with topiramate, compared to placebo: ataxia 2.29 (99% CI 1.10 to 4.77; 4 studies); concentration difficulties 7.81 (99% CI 2.08 to 29.29; 6 studies; moderate‐certainty evidence); dizziness 1.52 (99% CI 1.07 to 2.16; 8 studies); fatigue 2.08 (99% CI 1.37 to 3.15; 10 studies); paraesthesia 3.65 (99% CI 1.58 to 8.39; 7 studies; moderate‐certainty evidence); somnolence 2.44 (99% CI 1.61 to 3.68; 9 studies); 'thinking abnormally' 5.70 (99% CI 2.26 to 14.38; 4 studies; high‐certainty evidence); and weight loss 3.99 (99% CI 1.82 to 8.72; 9 studies; low‐certainty evidence). Evidence of publication bias for the primary outcome was found (Egger test, P = 0.001). We rated all studies included in the review as having either low or unclear risk of bias. Overall, we assessed the evidence as moderate to high certainty due to the evidence of publication bias, statistical heterogeneity and imprecision, which was partially compensated for by large effect sizes. Authors' conclusions Topiramate has efficacy as an add‐on treatment for drug‐resistant focal epilepsy as it is almost three times more effective compared to a placebo in reducing seizures. The trials reviewed were of relatively short duration and provided no evidence for the long‐term efficacy of topiramate. Short‐term use of add‐on topiramate was shown to be associated with several adverse events. The results of this review should only be applied to adult populations as only one study included children. Future research should consider further examining the effect of dose

Is age a barrier to chemotherapy? Rates of treatment in older patients with breast, colon or lung cancer in England in 2014: A national registry study

Background Survival from cancer in older patients is poorer in the UK than other countries with similar health systems and wealth possibly due to undertreatment and increased toxicities in this specific population. This population-based observational study describes factors affecting systemic anticancer treatment (SACT) use in older patients in England. Methods We identified patients aged ≥70 with stage II-III breast cancer, stage III colon cancer and stage IIIB-IV non-small cell lung cancer (NSCLC) diagnosed in 2014 from a dataset collected by the National Health Service in England. We used logistic regression to estimate factors affecting likelihood of receiving SACT and performed separate regression analyses for each disease, adjusting for age, gender, stage at diagnosis, pathological features, performance status, Charlson comorbidity index, ethnicity and socioeconomic group. We assessed 2-year overall survival (OS) using Kaplan-Meier method. Case mix adjusted treatment rates and workload volume were calculated at hospital level and presented using funnel plots, stratified by age groups (<70 and ≥70) to allow for assessment of variation between centres. Results 36892 patients were identified: 19879 with stage II-III breast cancer, 5292 with stage III colon cancer and 11721 with stage IIIB-IV NSCLC. Patients over 70 were less likely to receive SACT compared to those aged under 70: breast 11.7% vs 64.6%, p < 0.001; colon 37.4% vs 79%, p < 0.001; NSCLC 33.5% vs 60.2%, p < 0.001. 2-year OS for patients receiving SACT was similar for patients aged ≥70 and <70: breast 91.5% (95% CI: 89.3%-93.2%) vs 96.4% (95% CI: 95.9%-96.7%); colon 84.8% (95% CI: 82.6%-86.8%) vs 88.3% (95% CI: 86.7%-89.8%); NSCLC 16.7% (95% CI: 15.1%-18.4%) vs 19.8% (95%CI: 18.5%-21.1%). Patients receiving SACT had better OS than those untreated. SACT rates varied widely between hospitals after adjusting for case-mix across all ages. Conclusions Our study suggests that several factors affect the likelihood of receiving SACT but after adjusting for these, age remains determinant. Identifying hospitals with significantly lower SACT rates should prompt local review of multidisciplinary team practice

Validating the use of hospital episode statistics data and comparison of costing methodologies for economic evaluation:An end-of-life case study from the cluster randomised triAl of PSA testing for prostate cancer (CAP)

Objectives To evaluate the accuracy of routine data for costing inpatient resource use in a large clinical trial and to investigate costing methodologies. Design Final-year inpatient cost profiles were derived using (1) data extracted from medical records mapped to the National Health Service (NHS) reference costs via service codes and (2) Hospital Episode Statistics (HES) data using NHS reference costs. Trust finance departments were consulted to obtain costs for comparison purposes. Setting 7 UK secondary care centres. Population A subsample of 292 men identified as having died at least a year after being diagnosed with prostate cancer in Cluster randomised triAl of PSA testing for Prostate cancer (CAP), a long-running trial to evaluate the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Results Both inpatient cost profiles showed a rise in costs in the months leading up to death, and were broadly similar. The difference in mean inpatient costs was £899, with HES data yielding ∼8% lower costs than medical record data (differences compatible with chance, p=0.3). Events were missing from both data sets. 11 men (3.8%) had events identified in HES that were all missing from medical record review, while 7 men (2.4%) had events identified in medical record review that were all missing from HES. The response from finance departments to requests for cost data was poor: only 3 of 7 departments returned adequate data sets within 6 months. Conclusions Using HES routine data coupled with NHS reference costs resulted in mean annual inpatient costs that were very similar to those derived via medical record review; therefore, routinely available data can be used as the primary method of costing resource use in large clinical trials. Neither HES nor medical record review represent gold standards of data collection. Requesting cost data from finance departments is impractical for large clinical trials.</p

Systematic review of the effect of policies to restrict the marketing of foods and non-alcoholic beverages to which children are exposed

This systematic review examined the effectiveness of policies restricting the marketing of foods and/or non-alcoholic beverages to children to inform updated World Health Organization (WHO) guidelines. Databases were searched to March 2020. Inclusion criteria were primary studies of any design assessing implemented policies to restrict food marketing to children (0–19 years). Critical outcomes were exposure to and power of marketing, dietary intake, choice, preference, and purchasing. Important outcomes were purchase requests, dental caries, body weight, diet-related noncommunicable diseases, product change, and unintended consequences. Forty-four observational studies met inclusion criteria; most were moderate quality. Pooling was conducted using vote counting by direction of effect, and GRADE was used to judge evidence certainty. Evidence suggests food marketing policies may result in reduced purchases of unhealthy foods and in unintended consequences favorable for public health. Desirable or potentially desirable (for public health) effects of policies on food marketing exposure and power were also found. Evidence on diet and product change was very limited. The certainty of evidence was very low for four outcomes (exposure, power, dietary intake, and product change) and low for two (purchasing and unintended consequences). Policies can effectively limit food marketing to children; policymakers should prioritize mandatory approaches aligned with WHO recommendations

Association of Food and Nonalcoholic Beverage Marketing with Children and Adolescents' Eating Behaviors and Health: A Systematic Review and Meta-analysis

Importance: There is widespread interest in the effect of food marketing on children; however, the comprehensive global evidence reviews are now dated. Objective: To quantify the association of food and nonalcoholic beverage marketing with behavioral and health outcomes in children and adolescents to inform updated World Health Organization guidelines. Data Sources: Twenty-two databases were searched (including MEDLINE, CINAHL, Web of Science, Embase, and The Cochrane Library) with a publication date limit from January 2009 through March 2020. Study Selection: Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines were followed. Inclusion criteria were primary studies assessing the association of food marketing with specified outcomes in children and adolescents (aged 0-19 years). Exclusion criteria were qualitative studies or those on advertising of infant formula. Of 31063 articles identified, 96 articles were eligible for inclusion in the systematic review, and 80 articles in the meta-analysis (19372 participants). Data Extraction and Synthesis: Two reviewers independently extracted data. Random-effects models were used for meta-analyses; meta-regressions, sensitivity analyses, and P curve analyses were also performed. Where appropriate, pooling was conducted using combining P values and vote counting by direction of effect. Grading of Recommendations Assessment, Development, and Evaluation was used to judge certainty of evidence. Main Outcomes and Measures: Critical outcomes were intake, choice, preference, and purchasing. Important outcomes were purchase requests, dental caries, body weight, and diet-related noncommunicable diseases. Results: Participants totaled 19372 from 80 included articles. Food marketing was associated with significant increases in intake (standardized mean difference [SMD], 0.25; 95% CI, 0.15-0.35; P 76%) was unexplained by sensitivity or moderator analyses. The combination of P values for purchase requests was significant but no clear evidence was found for an association of marketing with purchasing. Data on dental health and body weight outcomes were scarce. The certainty of evidence was graded as very low to moderate for intake and choice, and very low for preference and purchasing. Conclusions and Relevance: In this systematic review and meta-analysis, food marketing was associated with increased intake, choice, preference, and purchase requests in children and adolescents. Implementation of policies to restrict children's exposure is expected to benefit child health

Life after prostate cancer diagnosis: protocol for a UK-wide patient-reported outcomes study

Background: Prostate cancer and its treatment may impact physically, psychologically and socially; affecting the health-related quality of life of men and their partners/spouses. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UK-wide patient-reported outcomes study which will generate information to improve the health and well-being of men with prostate cancer. Methods and analysis: Postal surveys will be sent to prostate cancer survivors (18–42 months postdiagnosis) in all 4 UK countries (n=∼70 000). Eligible men will be identified and/or verified through cancer registration systems. Men will be surveyed twice, 12 months apart, to explore changes in outcomes over time. Second, separate cohorts will be surveyed once and the design will include evaluation of the acceptability of online survey tools. A comprehensive patient-reported outcome measure has been developed using generic and specific instruments with proven psychometric properties and relevance in national and international studies. The outcome data will be linked with administrative health data (eg, treatment information from hospital data). To ensure detailed understanding of issues of importance, qualitative interviews will be undertaken with a sample of men who complete the survey across the UK (n=∼150) along with a small number of partners/spouses (n=∼30). Ethics and dissemination: The study has received the following approvals: Newcastle and North Tyneside 1 Research Ethics Committee (15/NE/0036), Health Research Authority Confidentiality Advisory Group (15/CAG/0110), NHS Scotland Public Benefit and Privacy Panel (0516-0364), Office of Research Ethics Northern Ireland (16/NI/0073) and NHS R&D approval from Wales, Scotland and Northern Ireland. Using traditional and innovative methods, the results will be made available to men and their partners/spouses, the funders, the NHS, social care, voluntary sector organisations and other researchers

Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.The research was independent and funded by the Welsh Assembly Government. RTE is supported by Public Health Wales. Additional support for LM and SM during write up was provided by The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UKCRC Public Health Research: Centre of Excellence. Funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council (RES-590-28-0005), Medical Research Council, the Welsh Assembly Government and the Wellcome Trust (WT087640MA), under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged